Title
Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients With Acute Traumatic Hemorrhage
Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage
Phase
Phase 3Lead Sponsor
Direction Centrale du Service de Santé des ArméesStudy Type
InterventionalStatus
RecruitingIndication/Condition
Trauma Acute Hemorrhage CoagulopathyIntervention/Treatment
Whole blood transfusion Fractionated blood products transfusion [red blood cells (65098), autologous plasma (9948), platelets (66091)]Study Participants
200The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain.
T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.
In recent years, terrorist attacks have confronted the investigator's healthcare system with a massive influx of victims of war weapon injuries. This new fact makes the efficiency of transfusion therapy crucial: hemorrhage is the leading cause of death from weapons of war, and the high number of victims of each attack changes the logistical approach.
The logistical problems with transfusion therapy, including red blood cell (PRBCs), plasma and platelet concentrates, are the speed of delivery and availability. Using whole blood is a pragmatic solution to overcome these problems. This solution has been used for many years by the French Army to ensure platelet transfusion in traumatic hemorrhages
The hypothesis of the T-STORHM study is that the use of whole blood is a solution in a context of civil trauma not effective less than component therapy (PRBCs, plasma and platelet concentrates) in the management of coagulopathy in patients admitted to hospital for traumatic hemorrhage.
Severe trauma patients with a life threatening bleeding will be managed with 3 whole blood bags for the 1st and 2nd pack. The later packs will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
Severe trauma patients with a life threatening bleeding will be managed with 3 packed red blood cells (PRBCs), 3 lyophilised plasma units and 1 dose of platelets for the 1st. The 2nd pack will consist of 3 packed red blood cells (PRBCs) and 3 lyophilised plasma units. Then, the later pack will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
Damage control resuscitation for trauma care using whole blood.
Damage control resuscitation for trauma care using component therapy.
Inclusion Criteria: Severe trauma patients requiring the initiation of a massive transfusion protocol determined on At least two Red flag score factors (according to pre-hospital data) : Suspected pelvic fracture Shock index (FC / PAS)> = 1 Microdose hemoglobin <13g Average blood pressure <70 mmHg Need for prehospital tracheal intubation AND at least two criteria of the Assessment of Blood Consumption (ABC) score established at the patient's arrival: Penetrating trauma Focused Abdominal Sonography for Trauma (FAST) echo positive Blood pressure <90 mmHg Respiratory rate >120 bpm AND/OR on the prediction of the practitioner (clinical diagnosis) in charge of the treatment of the injured person of the need to transfuse at least 4 PRBCs within 6 hours after the admission of the trauma patient Exclusion Criteria: Non-traumatic hemorrhage Patients transfused with more than two PRBCs before the initiation of the massive transfusion protocol. Anti-coagulation treatment Pregnancy Age < 18 years Patient refusing administration of blood products Patient transferred from another hospital Patient nor transported by a physician-staffed prehospital emergency medical system Burn patient (≥30% of body surface). Patient under specific known transfusion protocol (for example : allo immunization...)
